In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

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Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.

Device: Investigational Blood Glucose Monitoring System

Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.

Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:

The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.

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Ages Eligible for Study:

4 Years to 24 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Type 1 diabetes

Age 4 to 24 years

Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment

Has used a handheld game system to play video games within a year of enrollment

If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.

Is willing to complete all study procedures, with appropriate parent/guardian supervision

Exclusion Criteria:

Hemophilia or any other bleeding disorder

Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded

Infection with a blood borne pathogen (e.g., HIV, hepatitis)

Subject or parent/guardian is employee of competitive medical device company

Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study